Control-IQ+ technology

Control-IQ+ technology is a software-only automated insulin delivery system that controls basal insulin delivery from a compatible insulin pump based on continuous glucose monitor readings and user inputs. It is intended for managing Type 1 diabetes in persons 2 years and older, and Type 2 diabetes in persons 18 years and older, operating in three modes (Normal, Sleep, Exercise) with different glucose target ranges.

Control-IQ+ maintains identical technological specifications to its predicate device K232382 across all key parameters, including pump type, insulin profile delivery, basal rate range (10-600 mg/dL per unit), body weight setting range (20-440 lbs), total daily insulin range (5-200 units/day), and automatic correction bolus limits. The only material difference is the expanded indication to include Type 2 diabetes patients aged 18 and older, while the underlying algorithm design remains unchanged.

The device was evaluated according to IEC 62366-1 for human factors validation and the FDA guidance document 'Applying Human Factors and Usability Engineering to Medical Devices' (February 3, 2016). A summative human factors validation study with 30 Type 2 diabetic individuals was conducted, and a pivotal clinical trial with 319 subjects evaluated safety and effectiveness.

Substantial equivalence is established because: (1) the Control-IQ+ algorithm design is completely unchanged from the predicate; (2) all technological and functional specifications remain identical; (3) the expansion to Type 2 diabetes users aged 18+ represents a new population rather than a new mechanism, supported by clinical trial data demonstrating safety and effectiveness in this population; and (4) human factors validation with the new user population confirms safe and effective use. Since the device maintains the same function and only adds an indication supported by new clinical evidence, it does not raise different safety or effectiveness questions.